Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PBJ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
167 daysmedian FDA review time
299 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230211 | CranioXpand | KLS-Martin L.P. | 2023-11-21 | 299 | 0 |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-12-07 | 262 | 0 |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | 2017-05-05 | 163 | 0 |
| K150771 | RxG Distraction System | KLS Martin L.P. | 2015-08-27 | 156 | 0 |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Osteomed LP | 2013-06-03 | 167 | 0 |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Osteomed | 2012-08-22 | 113 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda